BACKGROUND
[0001] In humans, the two knee menisci reside between the thigh bone femur and the shin
bone tibia. While the ends of the thigh bone and the shin bone have a thin covering
of soft hyaline cartilage, the menisci are made of tough fibrocartilage and conform
to the surfaces of the bones they rest on. One meniscus rests on the medial tibial
plateau; this is the medial meniscus. The other meniscus rests on the lateral tibial
plateau; this is the lateral meniscus.
[0002] These menisci act to distribute body weight across the knee joint. Without the menisci,
the weight of the body would be unevenly applied to the femur and tibia. This uneven
weight distribution would cause the development of abnormal excessive forces leading
to early damage of the knee joint. The menisci also contribute to the stability of
the joint.
[0003] The menisci are nourished by small blood vessels but have a large area in the center
with no direct blood supply. This presents a problem when there is an injury to the
meniscus, as the avascular areas tend not to heal. Without the essential nutrients
supplied by blood vessels, healing cannot take place.
[0004] The two most common causes of a meniscal tear are traumatic injury and degenerative
processes, which are the most common tear seen in all ages of patients. Meniscal tears
can occur in all age groups. Traumatic tears are most common in active people aged
10-45. Traumatic tears are usually radial or vertical in the meniscus and more likely
to produce a moveable fragment that can catch in the knee and therefore require surgical
treatment.
[0005] US 2010/087857A1 (STONE KEVIN T et.al.) discloses a method in which a soft tissue repair device is
configured to deploy flexible anchors coupled together with a suture or strand, positioned
and anchored outside the tissue to reduce the tissue injury.
[0006] US 2004/122456 A1 discloses an anchor comprising a braided sleeve coupled to proximal and distal bushings.
One or more sutures are coupled to the distal bushing and extend through the proximal
bushing, which may slide along the suture(s) relative to the distal bushing, so that
the braided sleeve expands radially outward. Accordingly, after the anchor is disposed
through a tissue wall, application of tension to the sutures causes the anchor to
transition from an elongate reduced delivery profile to an expanded, substantially
disk-shaped deployed profile.
[0007] The foregoing examples of the related art and limitations related therewith are intended
to be illustrative and not exclusive. Other limitations of the related art will become
apparent to those of skill in the art upon a reading of the specification and a study
of the figures.
SUMMARY
[0008] The invention is defined in the appended claims.
[0009] The following embodiments and aspects thereof are described and illustrated in conjunction
with systems, tools and methods which are meant to be exemplary and illustrative,
not limiting in scope.
[0010] There is provided, in accordance with an embodiment, a device comprising: a flexible
tube comprising a first collapsible end portion; a first actuating element segment
secured to the first collapsible end portion and extending along the first collapsible
end portion, wherein, when the first collapsible end portion is threaded through a
first aperture and the first actuating element segment is pulled proximally, the first
collapsible end portion collapses proximally and forms a bulge larger than the first
aperture, thereby anchoring the flexible tube against a rim of the first aperture.
[0011] In some embodiments, the flexible tube further comprises a second collapsible end
portion, and the device further comprises a second actuating element segment secured
to the second collapsible end portion and extending along the second collapsible end
portion, wherein, when the first and second collapsible end portions are threaded
through the first aperture and a second aperture, respectively, and the first and
second actuating element segments are pulled proximally, each of the first and second
collapsible end portions collapses proximally and forms a bulge larger than a respective
one of the first and second apertures, thereby anchoring the flexible tube against
a rim of a respective one of the first and second apertures.
[0012] In some embodiments, an end portion of each of the first and second actuating element
segments is located externally to the flexible tube.
[0013] In some embodiments, each of the first and the second actuating element segments
extends along an inner void of a respective one of the first and second collapsible
end portions and wherein each of the first and second collapsible end portions collapses
into the inner void of the respective one of the first and second collapsible end
portions.
[0014] In some embodiments, each of the first and second actuating element segments is threaded
laterally and repeatedly through a respective one of the first and second collapsible
end portions, and wherein the first and second actuating element segments are pulled
proximally, each of the first and second collapsible end portions folds laterally
and repeatedly on itself.
[0015] In some embodiments, each of the first and second collapsible end portions comprises
a hardened portion located along a respective one of the first and second collapsible
end portions at a predefined distance from a tip of the respective one of the first
and second collapsible end portions, and wherein when the first and second actuating
element segments are pulled proximally: each of the first and second collapsible end
portions collapses into a section of an inner void of a respective one of the first
and second collapsible end portions formed between the tip and the hardened portion
of the respective one of the first and second collapsible end portions, and the hardened
portion of each of the first and second collapsible end portions collapses into the
remainder of the inner void of the respective one of the first and second collapsible
end portions.
[0016] In some embodiments, each of the first and second collapsible end portions comprises
a hardened tip, the first actuating element segment is secured to the hardened tip
of the first collapsible end portion, and the second actuating element segment is
secured to the hardened tip of the second collapsible end portion.
[0017] In some embodiments, the hardened tip of each of the first and second collapsible
end portions comprises barbs, and wherein the barbs are configured to secure each
hardened tip to a respective one of the first and second collapsible end portions
when it is collapsed.
[0018] In some embodiments, the device further comprises a first actuating element comprising
the first actuating element segment and a second actuating element comprising the
second actuating element segment.
[0019] In some embodiments, the first and second end portions are a tubular mesh.
[0020] In some embodiments, the first and second actuating element segment selected from
a group consisting of: a thread and a rigid roll.
[0021] There is further provided, in accordance with an embodiment, a device comprising
a flexible tube, the flexible tube comprising: an end portion comprising a first elongated
hardened element located at a tip of the end portion; a collapsible end portion comprising
a second elongated hardened element threaded thereon; and an actuating element secured
to the collapsible end portion, wherein, when the end portion and the collapsible
end portion are threaded through two apertures, respectively, and the actuating element
is pulled proximally, the collapsible end portion collapses proximally and forms a
bulge in vicinity to the second elongated hardened element, and wherein: a length
dimension of the first elongated hardened element is larger than a respective one
of the two apertures, the bulge and a length dimension of the second elongated hardened
element are larger than a respective one of the two apertures, thereby anchoring the
flexible tube against a rim of each of the two apertures.
[0022] In some embodiments, each of the first and second elongated hardened elements has
an involute shape.
[0023] In some embodiments, the first elongated hardened element and the second elongated
hardened element are made of polymer.
[0024] In some embodiments, the collapsible end portion comprises a hardened tip and the
actuating element is secured to the hardened tip.
[0025] In some embodiments, the collapsible end portion is a a tubular mesh.
[0026] In some embodiments, the actuating element is selected from a group consisting of:
a thread and a rigid roll.
[0027] There is further provided, in accordance with an embodiment, a device comprising:
a flexible tube comprising: a first end portion comprising a first elongated hardened
element located at a tip of the end portion; a second end portion comprising: a second
elongated hardened element threaded thereon, a pulling anchor located along the second
end portion, and a collapsible segment extending from the pulling anchor towards a
middle portion of the flexible tube; and an actuating element secured to the pulling
anchor and extending along the second end portion towards the middle portion of the
flexible tube; wherein, when: the first end portion is threaded through a first aperture
smaller than a length dimension of the first elongated hardened element, and the second
end portion is threaded back and forth, at least once, through a second aperture smaller
than a length dimension of the second elongated hardened element, and such that the
second elongated hardened element and the pulling anchor are located at different
sides with respect to the second aperture, the actuating element is pulled proximally,
wherein the collapsible segment of the second end portion collapses towards the second
elongated hardened element and forms a bulge larger than the second aperture, thereby
anchoring the flexible tube against a rim of the first aperture and two rims at two
sides of the second aperture.
[0028] In some embodiments, each of the first and second elongated hardened elements has
an involute shape.
[0029] In some embodiments, each of the first and second elongated hardened elements is
made of polymer.
[0030] There is further provided, in accordance with an embodiment, a device for repairing
a tear in a meniscus tissue, the device comprising: a flexible tube comprising two
collapsible end portions; a first actuating element segment secured to the first collapsible
end portion and extending along the first collapsible end portion; and a second actuating
element segment secured to the second collapsible end portion and extending along
the second collapsible end portion, wherein, when the first and second collapsible
end portions are threaded through two apertures made in the meniscus tissue through
the tear, and the first and second actuating element segments are pulled proximally,
the first and second collapsible end portions each collapses proximally and forms
a bulge larger than a respective one of the two apertures, thereby anchoring the flexible
tube against a peripheral distal wall of the meniscus tissue.
[0031] In some embodiments, each actuating element segment of the first and second actuating
element segments exits the flexible tube through a middle portion of the flexible
tube.
[0032] In some embodiments, each one of the first and second actuating element segments
extends along an inner void of the respective one of the first and second collapsible
end portions and wherein each one of the first and second collapsible end portions
collapses into its inner void.
[0033] In some embodiments, each actuating element segment of the first and second actuating
element segments is threaded laterally and repeatedly through the respective one of
the first and second collapsible end portions, and wherein when the first and second
actuating element segments are pulled proximally, each one of the first and second
collapsible end portions folds laterally and repeatedly on itself.
[0034] In some embodiments, each of the first and second collapsible end portions comprises
a hardened portion located along a respective one of the first and second collapsible
end portions at a predefined distance from a tip of the respective one of the first
and second collapsible end portions, and wherein when the first and second actuating
element segments are pulled proximally: each of the first and second collapsible end
portions collapses into a section of an inner void of a respective one of the first
and second collapsible end portions formed between the respective tip and the respective
hardened portion, and the hardened portion of each of the first and second collapsible
end portions collapses into a remainder of the respective inner void.
[0035] In some embodiments: each of the first and second collapsible end portions comprises
a hardened tip, the first actuating element segment is secured to the hardened tip
of the first collapsible end portion, and the second actuating element segment is
secured to the hardened tip of the second collapsible end portion.
[0036] In some embodiments, the hardened tip of each of the first and second collapsible
end portions comprises barbs, and wherein the barbs are configured to secure each
hardened tip to each respective one of the first and second collapsible end portions
when it is collapsed.
[0037] In some embodiments, the device further comprises a first actuating element comprising
the first actuating element segment and a second actuating element comprising the
second actuating element segment.
[0038] In some embodiments, the first and second end portions are a tubular mesh.
[0039] In some embodiments, the first and second actuating element segment selected from
a group consisting of: a thread and a rigid roll.
[0040] There is further provided, in accordance with an embodiment, a device for repairing
a tear in a meniscus tissue, the device comprising: a flexible tube comprising: an
end portion comprising a first elongated hardened element located at a tip of the
end portion, a collapsible end portion comprising a second elongated hardened element
threaded thereon, and an actuating element secured to the collapsible end portion,
wherein, when: the end portion and the collapsible end portion are threaded through
two apertures, respectively, wherein the two apertures are made in the meniscus tissue
and through the tear, and the actuating element is pulled proximally, the second collapsible
end portion collapses proximally and forms a bulge in vicinity to the second elongated
hardened element, and wherein: a length dimension of the first elongated hardened
element is larger than a respective one of the two apertures, and the bulge and a
length dimension of the second elongated hardened element are larger than a respective
one of the two apertures, thereby anchoring the flexible tube against a peripheral
distal wall of the meniscus tissue.
[0041] In some embodiments, each of the first and second elongated hardened elements has
an involute shape.
[0042] In some embodiments, each of the first and second elongated hardened elements are
made of polymer.
[0043] In some embodiments, the collapsible end portion comprises a hardened tip and the
actuating element is secured to the hardened tip.
[0044] In some embodiments, the collapsible end portion is a tubular mesh.
[0045] In some embodiments, the actuating element is selected from a group consisting of:
a thread and a rigid roll.
[0046] There is further provided, in accordance with an embodiment, a device for repairing
a tear in a meniscus tissue, the device comprising: a flexible tube comprising: a
first end portion comprising a first elongated hardened element located at a tip of
the first end portion; a second end portion comprising: a second elongated hardened
element threaded thereon, a pulling anchor located along the second end portion, and
a collapsible segment extending from the pulling anchor towards a middle portion of
the flexible tube; and an actuating element secured to the pulling anchor and extending
along the second end portion towards the middle portion of the flexible tube; wherein,
when: the first end portion is threaded through a first aperture smaller than a length
dimension of the first elongated hardened element, and the second end portion is threaded
back and forth through a second aperture, smaller than a length dimension of the second
elongated hardened element, and such that the second elongated hardened element and
the pulling anchor are located at different sides with respect to the second aperture,
and wherein the first aperture and the second aperture are made in the meniscus tissue
through the tear, the actuating element is pulled proximally, wherein the collapsible
segment of the second end portion collapses towards the second elongated hardened
element and forms a bulge larger than the second aperture, thereby anchoring the flexible
tube to the meniscus tissue.
[0047] In some embodiments, each of the first and second elongated hardened elements has
an involute shape.
[0048] In some embodiments, each of the first and second elongated hardened elements are
made of polymer.
[0049] In some embodiments, the second end portion is a tubular mesh.
[0050] In some embodiments, the actuating element is selected from a group consisting of:
a thread and a rigid roll.
[0051] There is further provided, in accordance with an embodiment, a kit for repairing
a tear in a meniscus tissue, the kit comprising: an implant comprising: a flexible
tube comprising two collapsible end portions, a first actuating element segment secured
to the first collapsible end portion and extending along the first collapsible end
portion, and a second actuating element segment secured to the second collapsible
end portion and extending along the second collapsible end portion; and an applicator
configured to deploy the implant in the meniscus tissue by puncturing the meniscus
tissue to form two apertures passing through the tear and threading the first and
second collapsible end portions through the two apertures; wherein, when: the first
and second collapsible end portions are threaded through the meniscus tissue, and
the first and second actuating element segments are pulled proximally, the first and
second collapsible end portions each collapses proximally and forms a bulge larger
than a respective one of the two apertures, thereby anchoring the implant against
a peripheral distal wall of the meniscus tissue.
[0052] In some embodiments, each actuating element segment of the first and second actuating
element segments exits the flexible tube through a middle portion of the flexible
tube.
[0053] In some embodiments, each one of the first and second actuating element segments
extends along an inner void of the respective one of the first and second collapsible
end portions and wherein each one of the first and second collapsible end portions
collapses into its inner void.
[0054] In some embodiments, each actuating element segment of the first and second actuating
element segments is threaded laterally and repeatedly through the respective one of
the first and second collapsible end portions, and wherein when the first and second
actuating element segments are pulled proximally, each one of the first and second
collapsible end portions folds laterally and repeatedly on itself.
[0055] In some embodiments, each of the first and second collapsible end portions comprises
a hardened portion located along a respective one of the first and second collapsible
end portions at a predefined distance from a tip of the respective one of the first
and second collapsible end portions, and wherein when the first and second actuating
element segments are pulled proximally: each of the first and second collapsible end
portions collapses into a section of an inner void of a respective one of the first
and second collapsible end portions formed between the respective tip and the respective
hardened portion, and the hardened portion of each of the first and second collapsible
end portions collapses into a remainder of the respective inner void.
[0056] In some embodiments: each of the first and second collapsible end portions comprises
a hardened tip, the first actuating element segment is secured to the hardened tip
of the first collapsible end portion, and the second actuating element segment is
secured to the hardened tip of the second collapsible end portion.
[0057] In some embodiments, the hardened tip of each of the first and second collapsible
end portions comprises barbs, and wherein the barbs are configured to secure each
hardened tip to a respective one of the first and second collapsible end portions
when it is collapsed.
[0058] In some embodiments, the kit further comprises a first actuating element comprising
the first actuating element segment and a second actuating element comprising the
second actuating element segment.
[0059] In some embodiments, the applicator comprises: a first and a second tubular needles,
wherein each one of the first and second tubular needles is configured to puncture
the meniscus tissue to form a respective one of the two apertures, and wherein each
one of the first and second tubular needles comprises: an opening configured to allow
insertion of a tip of a respective one of the first and second collapsible end portions
into a respective one of the first and second tubular needles, and a rod positioned
there within and configured to maintain the tip of the respective one of the first
and second collapsible end portions in place within the respective one of the first
and second tubular needles.
[0060] In some embodiments, the applicator comprises: a tubular needle configured to puncture
the meniscus tissue to form the two apertures, wherein the tubular needle comprises
a first and a second openings, each configured to allow insertion of a tip of a respective
one of the first and second collapsible end portions into the tubular needle, and
a first and a second rod positioned within the tubular needle and wherein each one
of the first and second rods is configured to maintain the tip of a respective one
of the first and second collapsible end portions in place within the tubular needle.
[0061] There is further provided, in accordance with an embodiment, a kit for repairing
a tear in a meniscus tissue, the kit comprising: an implant comprising: a flexible
tube, the flexible tube comprising: an end portion comprising a first elongated hardened
element located at a tip of the end portion, and a collapsible end portion comprising
a second elongated hardened element threaded thereon, and an actuating element secured
to the collapsible end portion; and an applicator configured to deploy the flexible
tube in the meniscus tissue by puncturing the meniscus tissue to form two apertures
passing through the tear and threading the end portion and the collapsible end portion
through the two apertures, respectively, wherein, when: the end portion and the collapsible
end portion are threaded through the two apertures, respectively, and the actuating
element is pulled proximally, the collapsible end portion collapses proximally and
forms a bulge in vicinity to the second elongated hardened element, and wherein: a
length dimension of the first elongated hardened element is larger than a respective
one of the two apertures, the bulge and a length dimension of the second elongated
hardened element are larger than a respective one of the two apertures, thereby anchoring
the flexible tube against a peripheral distal wall of the meniscus tissue.
[0062] In some embodiments, each of the first and second elongated hardened elements has
an involute shape.
[0063] In some embodiments, each of the first and second elongated hardened elements are
made of polymer.
[0064] In some embodiments, the collapsible end portion comprises a hardened tip and the
actuating element is secured to the hardened tip.
[0065] In some embodiments, the applicator comprises: a first tubular needle configured
to puncture the meniscus tissue to form a respective one of the two apertures, the
first tubular needle comprising: a first opening configured to allow insertion of
the first elongated hardened element into the first tubular needle, and a first rod
positioned there within and configured to maintain the first elongated hardened element
in place within the first tubular needle; a second tubular needle configured to puncture
the meniscus tissue to form a respective one of the two apertures, the second tubular
needle comprising: a second opening configured to allow insertion of the second elongated
hardened element and of the collapsible end portion into the second tubular needle,
and a second rod positioned there within and configured to maintain the second elongated
hardened element and the collapsible end portion in place within the second tubular
needle.
[0066] There is further provided, in accordance with an embodiment, a kit for repairing
a tear in a meniscus tissue, the kit comprising: an implant comprising: a flexible
tube, the flexible tube comprising: a first end portion comprising a first elongated
hardened element located at a tip of the first end portion, and a second end portion
comprising a second elongated hardened element threaded thereon and a pulling anchor
located along the second end portion, and an actuating element secured to the pulling
anchor and extending along the second end portion; and an applicator configured to
deploy the flexible tube in the meniscus tissue by puncturing the meniscus tissue
to form two apertures passing through the tear and threading the first end portion
and the second end portion through the two apertures, respectively, wherein, when:
the first end portion and the second end portion are threaded through the two apertures,
respectively, and the actuating element is pulled proximally, a collapsible segment
of the second end portion, extending from the pulling anchor towards a middle portion
of the flexible tube, collapses towards the second elongated hardened element and
forms a bulge larger than the second aperture, and wherein: a length dimension of
the first elongated hardened element is larger than a respective one of the two apertures,
a length dimension of the second elongated hardened element is larger than a respective
one of the two apertures, thereby anchoring the flexible tube to the meniscus tissue.
[0067] In some embodiments, each of the first and second elongated hardened elements has
an involute shape.
[0068] In some embodiments, each of the first and second elongated hardened elements are
made of polymer.
[0069] In some embodiments, the applicator comprises: a first tubular needle configured
to puncture the meniscus tissue to form a respective one of the two apertures, the
first tubular needle comprising: a first opening configured to allow insertion of
the first elongated hardened element into the first tubular needle, and a first rod
positioned there within and configured to maintain the first elongated hardened element
in place within the first tubular needle; a second tubular needle configured to puncture
the meniscus tissue to form a respective one of the two apertures, the second tubular
needle comprising: a second opening configured to allow insertion of the second elongated
hardened element and of the second end portion into the second tubular needle, and
a second rod positioned there within and configured to maintain the second elongated
hardened element and the second end portion in place within the second tubular needle.
[0070] There is further provided, in accordance with an embodiment, a method for repairing
a tear in a meniscus tissue, the method comprising: puncturing the meniscus tissue
in two locations in a proximal wall of the meniscus tissue to form two apertures passing
through the tear and exiting the meniscus tissue through a peripheral distal wall
of the meniscus tissue; threading two collapsible end portions of a flexible tube
through the two apertures, respectively; pulling proximally a first and a second actuating
element segments secured to the first and second collapsible end portions and extending
along the first and second collapsible end portions, respectively, wherein the first
and second collapsible end portions each collapses proximally and forms a bulge larger
than a respective one of the two apertures, thereby anchoring the flexible tube against
the peripheral distal wall of the meniscus tissue.
[0071] In some embodiments, each one of the first and second actuating element segments
exits the flexible tube through a middle portion of the flexible tube.
[0072] In some embodiments, each one of the first and second actuating element segments
extends along an inner void of a respective one of the first and second collapsible
end portions and wherein each one of the first and second collapsible end portions
collapses into its inner void.
[0073] In some embodiments, each one of the first and second actuating element segments
is threaded laterally and repeatedly through a respective one of the first and second
collapsible end portions, and wherein pulling proximally the first and second actuating
element segments, folds each one of the first and second collapsible end portions
laterally and repeatedly on itself.
[0074] In some embodiments, each one of the first and second collapsible end portions comprises
a hardened portion located along a respective one of the first and second collapsible
end portions at a predefined distance from a tip of the respective one of the first
and second collapsible end portions, and wherein pulling proximally each of the first
and second actuating element segments: collapses each of the first and second collapsible
end portions into a section of an inner void of a respective one of the first and
second collapsible end portions formed between the respective tip and the respective
hardened portion, and collapses the hardened portion of each of the first and second
collapsible end portions into a remainder of the respective inner void.
[0075] In some embodiments: each of the first and second collapsible end portions comprises
a hardened tip, the first actuating element segment is secured to the hardened tip
of the first collapsible end portion, and the second actuating element segment is
secured to the hardened tip of the second collapsible end portion.
[0076] In some embodiments, the hardened tip of each of the first and second collapsible
end portions comprises barbs, and wherein the barbs are configured to secure each
hardened tip to a respective one of the first and second collapsible end portions
when it is collapsed.
[0077] In some embodiments, the method further comprises a first actuating element comprising
the first actuating element segment and a second actuating element comprising the
second actuating element segment.
[0078] In some embodiments, puncturing the meniscus tissue is performed by two tubular needles
of an applicator, the method further comprising placing a tip of each one of the first
and second collapsible end portions in the two tubular needles, respectively, wherein
the tip of each one of the first and second collapsible end portions is maintained
in place by a rod located within each one of the two tubular needles, respectively,
wherein threading of the two collapsible end portions further comprises retracting
the rod located within each one of the two tubular needles to let the tip of each
one of the first and second collapsible end portions out of a respective one of the
two tubular needles through an opening in each respective one of the two tubular needles.
[0079] There is further provided, in accordance with an embodiment, a method for repairing
a tear in a meniscus tissue, the method comprising: puncturing the meniscus tissue
in two locations in a proximal wall of the meniscus tissue to form two apertures passing
through the tear and exiting the meniscus tissue through a peripheral distal wall
of the meniscus tissue; threading an end portion of a flexible tube and a first elongated
hardened element located at a tip of the end portion through a respective one of the
two apertures, wherein the first elongated hardened element is placed beyond the peripheral
distal wall; threading a collapsible end portion of the flexible tube and a second
elongated hardened element of the collapsible end portion threaded thereon, through
a respective one of the two apertures, wherein the second elongated hardened element
and a section of the collapsible end portion extending distally there from are placed
beyond the peripheral distal wall; pulling proximally an actuating element segments
secured to the collapsible end portion and extending along the collapsible end portion,
wherein the section of the collapsible end portion collapses proximally and forms
a bulge in vicinity to the second elongated hardened element, and wherein: a length
dimension of the first elongated hardened element is larger than a respective one
of the two apertures, the bulge and a length dimension of the second elongated hardened
element are larger than a respective one of the two apertures, thereby anchoring the
flexible tube against a peripheral distal wall of the meniscus tissue.
[0080] In some embodiments, each of the first and second elongated hardened elements has
an involute shape.
[0081] In some embodiments, each of the first and second elongated hardened elements are
made of polymer.
[0082] In some embodiments, the collapsible end portion comprises a hardened tip and the
actuating element is secured to the hardened tip.
[0083] In some embodiments, puncturing of the meniscus tissue is performed by a first and
a second tubular needles of an applicator, the method further comprising: placing
the first elongated hardened element in the first tubular needle parallelly with respect
to the first tubular needle, wherein the first elongated hardened element is maintained
in place by a first rod located within the first tubular needle, and placing the second
elongated hardened element and the collapsible end portion in the second tubular needle,
wherein the second elongated hardened element is placed parallelly with respect to
the second tubular needle, and wherein the second elongated hardened element and the
collapsible end portion are maintained in place by a second rod located within the
first tubular needle, wherein: threading the end portion and the first elongated hardened
element comprises retracting the first rod to let the first elongated hardened element
out of the first tubular needle through a first opening of the first tubular needle,
and threading the collapsible end portion and the second elongated hardened element
comprises retracting the second rod to let the second elongated hardened element and
the collapsible end portion out of the second tubular needle through a second opening
of the second tubular needle.
[0084] There is further provided, in accordance with an embodiment, a method for repairing
a tear in a meniscus tissue, the method comprising: puncturing the meniscus tissue
in two locations in a proximal wall of the meniscus tissue to form a first and a second
apertures passing through the tear and exiting the meniscus tissue through a peripheral
distal wall of the meniscus tissue; threading a first end portion of a flexible tube
and a first elongated hardened element located at a tip of the first end portion through
the first aperture, wherein the first elongated hardened element is placed beyond
the peripheral distal wall; threading a second end portion of the flexible tube, back
and forth through the second aperture, wherein a second elongated hardened element
threaded on the second end portion and a pulling anchor located along the second end
portion are placed at different sides with respect to the second aperture; and pulling
proximally an actuating element secured to the pulling anchor and extending along
the second end portion, wherein a collapsible segment of the second end portion, extending
from the pulling anchor towards the middle portion of the flexible tube, collapses
towards the second elongated hardened element and forms a bulge larger than the second
aperture, and wherein: a length dimension of the first elongated hardened element
is larger than the first aperture, and a length dimension of the second elongated
hardened element is larger than the second aperture, thereby anchoring the flexible
tube to the meniscus tissue.
[0085] In some embodiments, puncturing of the meniscus tissue is performed by a first and
a second tubular needles of an applicator, the method further comprising: placing
the first elongated hardened element in the first tubular needle parallelly with respect
to the first tubular needle, wherein the first elongated hardened element is maintained
in place by a first rod located within the first tubular needle, and placing the second
elongated hardened element and the second end portion in the second tubular needle,
wherein the second elongated hardened element is placed parallelly with respect to
the second tubular needle, and wherein the second elongated hardened element and the
second end portion are maintained in place by a second rod located within the second
tubular needle, wherein: threading the end portion and the first elongated hardened
element comprises retracting the first rod to let the first elongated hardened element
out of the first tubular needle through a first opening of the first tubular needle,
and threading the second end portion and the second elongated hardened element comprises
retracting the second rod to let the second elongated hardened element and the second
end portion out of the second tubular needle through a second opening of the second
tubular needle.
[0086] There is further provided, in accordance with an embodiment, a method for joining
at least two elements, the method comprising: forming a first aperture passing through
the at least two elements; threading a first collapsible end portion of a flexible
tube through the first aperture; pulling proximally a first actuating element segment
secured to the first collapsible end portion and extending along the first collapsible
end portion, wherein the first collapsible end portion collapses proximally and forms
a bulge larger than the first aperture, thereby anchoring the flexible tube against
a rim of the first aperture.
[0087] In some embodiments, the method further comprises: forming a second aperture passing
through the at least two elements; threading a second collapsible end portion of the
flexible tube through the second aperture; and pulling proximally a second actuating
element segment secured to the second collapsible end portion and extending along
the second collapsible end portion, wherein the second collapsible end portion collapses
proximally and forms a bulge larger than the second aperture, thereby anchoring the
flexible tube against a rim of the second aperture.
[0088] In some embodiments, each one of the first and second actuating element segments
exits the flexible tube through a middle portion of the flexible tube.
[0089] In some embodiments, each one of the first and second actuating element segments
extends along an inner void of a respective one of the first and second collapsible
end portions and wherein each one of the first and second collapsible end portions
collapses into its inner void.
[0090] In some embodiments, each one of the first and second actuating element segments
is threaded laterally and repeatedly through a respective one of the first and second
collapsible end portions, and wherein pulling proximally each one of the first and
second actuating element segments, folds each one of the first and second collapsible
end portions laterally and repeatedly on itself, respectively.
[0091] In some embodiments, each one of the first and second collapsible end portions comprises
a hardened portion located along a respective one of the first and second collapsible
end portions at a predefined distance from a tip of the respective one of the first
and second collapsible end portions, and wherein pulling proximally each one of the
first and second actuating element segments: collapses each one of the first and second
collapsible end portions, respectively, into a section of an inner void of a respective
one of the first and second collapsible end portions formed between the respective
tip and the respective hardened portion, and collapses the hardened portion of each
one of the first and second collapsible end portions into a remainder of the respective
inner void.
[0092] In some embodiments: each one of the first and second collapsible end portions comprises
a hardened tip, the first actuating element segment is secured to the hardened tip
of the first collapsible end portion, and the second actuating element segment is
secured to the hardened tip of the second collapsible end portion.
[0093] In some embodiments, the hardened tip of each one of the first and second collapsible
end portions comprises barbs, and wherein the barbs are configured to secure the hardened
tip of each one of the first and second collapsible end portions to a respective one
of the first and second collapsible end portions when it is collapsed.
[0094] In some embodiments, the method further comprises a first actuating element comprising
the first actuating element segment and a second actuating element comprising the
second actuating element segment.
[0095] There is further provided, in accordance with an embodiment, a method for joining
at least two elements, the method comprising: forming two apertures passing through
the at least two elements; threading an end portion of a flexible tube and a first
elongated hardened element located at a tip of the end portion through a respective
one of the two apertures, wherein the first elongated hardened element is placed beyond
a distal rim of the respective one of the two apertures; threading a collapsible end
portion of the flexible tube and a second elongated hardened element threaded thereon
through a respective one of the two apertures, wherein the second elongated hardened
element and a section of the collapsible end portion extending distally there from
are placed beyond a distal rim of the respective one of the two apertures; pulling
proximally an actuating element secured to the collapsible end portion and extending
along the collapsible end portion, wherein the section of the collapsible end portion
collapses proximally and forms a bulge in vicinity to the second elongated hardened
element, and wherein: a length dimension of the first elongated hardened element is
larger than a respective one of the two apertures, the bulge and a length dimension
of the second elongated hardened element are larger than a respective one of the two
apertures, thereby anchoring the flexible tube against the distal rim of each one
of the two apertures.
[0096] In some embodiments, each of the first and second elongated hardened elements has
an involute shape.
[0097] In some embodiments, each of the first and second elongated hardened elements are
made of polymer.
[0098] In some embodiments, the collapsible end portion comprises a hardened tip and the
actuating element is secured to the hardened tip.
[0099] There is further provided, in accordance with an embodiment, a method for joining
at least two elements, the method comprising: forming a first and a second aperture
passing through the at least two elements; threading a first end portion of a flexible
tube and a first elongated hardened element located at a tip of the first end portion
through the first aperture, wherein the first elongated hardened element is placed
beyond a distal rim of the respective one of the two apertures; threading a second
end portion of the flexible tube, back and forth through the second aperture, wherein
a second elongated hardened element threaded on the second end portion and a pulling
anchor located along the second end portion are placed at different sides with respect
to the second aperture; and pulling proximally an actuating element secured to the
pulling anchor and extending along the second end portion, wherein a collapsible segment
of the second end portion, extending from the pulling anchor towards a middle portion
of the flexible tube, collapses towards the second elongated hardened element and
forms a bulge larger than the second aperture, and wherein: a length dimension of
the first elongated hardened element is larger than the first aperture, and a length
dimension of the second elongated hardened element is larger than the second aperture,
thereby anchoring the flexible tube to the two elements.
[0100] In addition to the exemplary aspects and embodiments described above, further aspects
and embodiments will become apparent by referenFinace to the figures and by study
of the following detailed description.
BRIEF DESCRIPTION OF THE FIGURES
[0101] Exemplary embodiments are illustrated in referenced figures. Dimensions of components
and features shown in the figures are generally chosen for convenience and clarity
of presentation and are not necessarily shown to scale. The figures are listed below.
Fig. 1 shows a side view of an exemplary device including a mesh flexible tube and
two actuating elements;
Fig. 2 shows a vertical section of the device of Fig.1 when it is arranged in a U-shape;
Figs. 3A-3D show perspective views of a collapsible end portion of a mesh flexible
tube of the device of Fig. 1 in different states while an actuating element segment
coupled with the collapsible end portion is pulled;
Figs. 4A-4D show semi-transparent vertical sections of the collapsible end portion
of Figs. 3A-3D, respectively;
Fig. 5A shows a perspective view of a collapsible end portion of an exemplary mesh
flexible coupled with a laterally and repeatedly threaded actuating element segment;
Fig. 5B shows a perspective view of the collapsible end portion of Fig. 5A when the
actuating element segment is pulled;
Fig. 5C shows a perspective view of a collapsible end portion of another exemplary
mesh flexible coupled with a laterally and repeatedly threaded actuating element segment;
Fig. 5D shows a perspective view of the collapsible end portion of Fig. 5C when the
actuating element segment is pulled;
Fig 6A shows a semi-transparent view of a collapsible end portion of a mesh flexible
tube including a hardened coupled with an actuating element segment and a hardened
portion located along the collapsible end portion;
Figs. 6B-6C show semi-transparent vertical sections of the collapsible end portion
of Fig. 6A in different states while the actuating element segment is pulled;
Fig 7A shows a semi-transparent vertical section of a collapsible end portion of a
mesh flexible tube coupled with an actuating element segment and including a hardened
tip with barbs located at two opposite sides of the hardened tip;
Figs. 7B-7C show semi-transparent vertical sections of vertical sections of the collapsible
end portion of Fig. 7A in different states while the actuating element segment is
pulled;
Fig 7D shows a semi-transparent view of a collapsible end portion of a mesh flexible
tube coupled with an actuating element segment and including a hardened tip with barbs
located at one side of the hardened tip;
Figs. 7E-7F show semi-transparent vertical sections of vertical sections of the collapsible
end portion of Fig. 7D in different states while the actuating element segment is
pulled;
Fig. 8A shows a perspective top view of an exemplary applicator of a kit which includes
two tubular needles when one of the tubular needles is in an operative mode;
Fig. 8B shows a perspective top view of the exemplary applicator of Fig 8A when the
other tubular needle is in an operative mode;
Fig. 8C shows a perspective top view of the exemplary applicator of Fig 8A when in
a non-operative mode;
Fig. 9A shows an isometric top view of a tubular needle of an exemplary applicator;
Fig. 9B shows a cross-section along line A-A of the tubular needle of Fig. 9A;
Fig. 9C shows a cross section along line B-B of the tubular needle of Fig. 9A;
Fig. 10 shows a side view, partially cross-sectional, of a vertical section of an
exemplary kit including an applicator and an implant;
Fig. 11 shows a top view of an exemplary kit including an applicator and an implant,
where the applicator includes a tubular needle, and when the mesh implant is positioned
in the applicator;
Fig. 12 shows a flowchart of a method for joining at least two elements, constructed
and operative in accordance with an embodiment of the disclosed technique;
Fig. 13A shows a semi-transparent vertical section of a device including two separate
actuating elements, when deployed and after pulling of the actuating elements;
Fig. 13B shows a side view of a middle portion of the device of Fig. 13A, where the
actuating elements are tied;
Figs. 14A-14E show top views of an applicator deploying an implant in a meniscus tissue
according to the method of Fig. 12;
Figs. 15A and 15B show side views of an exemplary device including a flexible mesh
tube arranged in a U-shape, where the flexible mesh tube includes two elongated hardened
elements, in a non-collapsed mode and in a collapsed mode, respectively;
Figs. 16A shows a perspective view of a thread when twisted on itself to form an involute
elongated hardened element;
Fig. 16B shows a side view the thread of Fig. 16A including the involute elongated
hardened element;
Fig. 17A shows a cross-section of an elongated hardened element including a bore and
made of solid polymer;
Fig. 17B shows a cross-section of an exemplary device including two elongated hardened
elements such as the elongated hardened element of Fig. 17A and arranged in a U-shape;
Fig 17C shows a collapsible end portion of a flexible mesh tube of the device of Fig.
17B, when collapsed;
Fig.18A shows a top transparent view of an exemplary kit including an applicator and
an implant;
Fig.18B shows a top transparent view of another exemplary kit including an applicator
and an implant;
Fig. 19 shows a flowchart of another method for joining at least two elements, constructed
and operative in accordance with an embodiment of the disclosed technique;
Figs. 20A-20G show top views, partially transparent, of an applicator deploying an
implant in a meniscus tissue according to the method of Fig. 19;
Fig. 21A shows a side view of a device when it is arranged in a U shape;
Fig. 21B shows a side view of a portion of the device of Fig. 21A including the second
end portion of a flexible mesh tube of the device and an actuating element of the
device;
Fig. 22 shows a flowchart of a further method for joining at least two elements, constructed
and operative in accordance with an embodiment of the disclosed technique; and
Figs. 23A-23E show side and perspective views of an implant deployed in a meniscus
tissue according to the method of Fig. 22.
DETAILED DESCRIPTION
[0102] The disclosed devices, kits and methods may be used for anchoring in various industrial
and medical fields. Generally, the disclosed device may include an elongated tube,
whether hollow or solid, and an actuating element secured to an end of the elongated
tube; an end portion of the tube may be inserted into an aperture, and the actuating
element may then be pulled. During this pulling, a portion of the elongated tube may
collapse (such as form multiple folds one over the other) and form a bulge which serves
as an anchor at an opposite side of the aperture.
[0103] This anchor may be used for firmly securing the tube to an element in which the aperture
is situated. Optionally, in order to release the anchor, the actuating element may
be pushed, thereby expanding the collapsed portion of the tube and eliminating the
bulge.
[0104] In a more complex variety of the device, two or more such bulges may be formed at
different areas of the tube, such as at its two opposing ends or even along its length.
This may allow the convenient anchoring of two or more elements to one another.
[0105] In the medical field, the present device may be used in surgical procedures where
fixation of two or more tissues to one another is required. Examples include fixation
of bones, soft tissues, or any combination thereof. Additionally, one or more surgical
implants may be affixed to a bodily tissue using the device.
[0106] For simplicity of discussion, the present devices, kits and methods are discussed
herein with reference to meniscus repair, in which a tear in the meniscus tissue is
repaired by affixing together the two opposing sides of the tear. However, those of
skill in the art will recognize that the devices, kits and methods may be similarly
used for many other medical and/or industrial applications.
[0107] The use of the disclosed devices, kits and methods in meniscus repair procedures
may be relatively easy and fast and may provide a firm and reliable closure of the
tear and minimization of the damage.
[0108] The term "two elements", as referred to herein with respect to joining of these elements,
may relate to two separate elements or to two portions of the same element (i.e.,
each portion is referred to as an element). For example, two separate elements may
be joined together or two portions of an element may be joined together, for example,
to close a tear in the element which divides the element into two portions.
[0109] The term "collapse" and its derivations, as referred to herein with respect to some
component of the disclosed devices and kits, including a portion of the flexible tube
of the disclosed devices and kits, may relate to the folding of the component on or
into itself.
[0110] The term "pulling proximally" and its derivations as referred to herein with respect
to an actuating element, an actuating element segment or a flexible tube of the disclosed
devices and kits, may include each direction which causes a portion of a flexible
tube of the disclosed devices and kits to collapse.
[0111] Disclosed herein is a device, which may include a flexible tube and an actuating
element segment. The flexible tube may include a collapsible end portion. The actuating
element segment may extend along the collapsible end portion. The actuating element
segment may be secured to the collapsible end portion.
[0112] The collapsible end portion may be threaded through an aperture. When the first actuating
element segment is pulled proximally, the collapsible end portion may collapse proximally
and form a bulge larger than the first aperture. Thus, the flexible tube may be anchored
against a rim of the aperture.
[0113] The flexible tube may be made of flexible materials such as rubber and/or a woven
material (i.e., a mesh), e.g., woven threads. The collapsible end portion may be made
of materials which collapse when applying force on them, e.g., in a specific direction.
Thus, the collapsible end portion may be, for example, a mesh collapsible end portion,
i.e., made of a woven material or a knitted material. The actuating element segment
may be, for example, a thread or a rigid roll.
[0114] In some embodiments, the flexible tube may include two collapsible end portions and
two actuating element segments, correspondingly. Reference is now made to Figs. 1-4D.
Fig. 1 shows a side view of an exemplary device 100 including a mesh flexible tube
110 and two actuating elements 140A and 140B. Fig. 2 shows a vertical section of device
100 of Fig.1 when it is arranged in a U-shape. Figs. 3A-3D show perspective views
of a collapsible end portion 120A of mesh flexible tube 110 of device 100 of Fig.
1 in different states while an actuating element segment coupled with collapsible
end portion 120A is pulled. Figs. 4A-4D show vertical sections of the collapsible
end portion of Figs. 3A-3D, respectively.
[0115] Exemplary device 100 may include a flexible mesh tube 110 and two actuating element
segments 140A and 140B. Flexible mesh tube 110 may include two collapsible end portions
120A and 120B and a middle portion 130. Each of collapsible end portions 120A and
120B may optionally include a hardened tip 150A and 150B, respectively. Actuating
element segments 140A and 140B may be secured to hardened tips 150A and 150B of collapsible
end portions 120A and 120B, respectively. However, in this and every other embodiment
of the specification, the term "hardened tip" may also relate to a configuration in
which an actuating element segment is secured to a collapsible end portion by other
means, such as glue, knotting and/or the like.
[0116] Each of actuating element segments 140A and 140B may extend along collapsible end
portions 120A and 120B, respectively. Actuating element segments 140A and 140B may
extend along an inner void of collapsible end portions 120A and 120B, respectively,
as shown in Fig. 2. An end portion of each of actuating element segments 140A and
140B may be located externally to flexible mesh tube 110, thus facilitating pulling
of actuating element segments 140A and 140B. The end portion of each of actuating
element segments 140A and 140B may exit flexible mesh tube 110 through an opening
160A and 160B in flexible mesh tube 110, respectively. Actuating element segments
140A and 140B may be segments of a single actuating element. Alternatively, device
110 may include two separate actuating elements, while one of the actuating elements
includes actuating element segment 140A and the other includes actuating element segment
140B.
[0117] Collapsible end portions 120A and 120B may be threaded through a first and a second
aperture, respectively, while leaving middle portion 130 out of the first and second
apertures. Thus, device 100 may be formed in a U-shape, as exemplified in Fig. 2,
in order to facilitate such threading. The end portions of actuating element segments
140A and 140B may be then positioned proximally (i.e., with respect to an operator
of device 100), facilitating proximal pulling of each of element segments 140A and
140B. Following the pulling of each of collapsible end portions 120A and 120B, they
may collapse proximally and respectively and form a bulge larger than a respective
one of the first and second apertures. Each of collapsible end portions 120A and 120B
may collapse into its inner void.
[0118] Hardened tips 150A and 150B may be formed, for example, by melting the material of
flexible mesh tube 110 and/or by over-molding a certain material or glue on the flexible
mesh tube. In some medical applications, due to biocompatibility concerns, it may
be desired to use the melting technique.
[0119] Hardened tips 150A and 150B may be of different shapes and other than rectangular,
as shown in Figs. 1 and 2.
[0120] Figs. 3A-3D and 4A-4D exemplify the collapsing of collapsible end portion 120A when
actuating element segment 140A is pulled proximally. In Fig. 3A and 4A actuating element
segment 140A is pulled proximally while the direction of pulling is indicated in Figs.
3A by an arrow and the letter "F", which stands for "Force". In Figs. 3B and 4B, hardened
tip 150A is pulled proximally by actuating element segment 140A and collapsible end
portion 120A begins to collapse into its inner void and a bulge is starting to form.
In Figs. 3C and 4C, collapsible end portion 120A continues to collapse while actuating
element segment 140A is still pulled proximally. In Figs. 3D and 4D, the pulling is
stopped and a final bulge is formed. By forming each bulge, larger than a respective
one of the first and second apertures, flexible mesh tube 110 may be anchored against
a rim of each one of the first and second apertures.
[0121] In some embodiments an actuating element segment may be threaded laterally and repeatedly
through a collapsible end portion. In such embodiments, when the actuating element
segment is pulled, the collapsible end portion may fold laterally and repeatedly on
itself. Reference is now made to Figs. 5A-5D. Fig. 5A shows a perspective view of
a collapsible end portion 210 of an exemplary mesh flexible tube 200 coupled a laterally
and repeatedly threaded actuating element segment 220. Fig. 5B shows a perspective
view of the collapsible end portion 210 of Fig. 5A when actuating element segment
220 is pulled. Collapsible end portion 210 may optionally include a hardened tip 230.
Actuating element segment 220 may be threaded laterally and repeatedly, for example,
twice, as shown in Fig. 5A. Thus, when pulled proximally, collapsible end portion
210 may fold on itself, as shown in Fig. 5B.
[0122] Fig. 5C shows a perspective view of a collapsible end portion of another exemplary
mesh flexible tube 250 coupled with a laterally and repeatedly threaded actuating
element segment 270. Mesh flexible tube 250 may be hollow or even solid; in the latter
case, segment 270 is threaded through the solid body of tube 250. Fig. 5D shows a
perspective view of the collapsible end portion of Fig. 5C when actuating element
segment 270 is pulled. Collapsible end portion 260 may optionally include a hardened
tip 280. Actuating element segment 270 may be threaded laterally and repeatedly through
collapsible end portion 260, for several times, as shown in Fig. 5C. Thus, when pulled
proximally, collapsible end portion 260 may fold on itself several times, as shown
in Fig. 5D.
[0123] Reference is now made to Figs. 6A-6C. Fig 6A shows a perspective transparent view
of a collapsible end portion 310 of a mesh flexible tube 300, optionally including
a hardened tip 330 coupled with an actuating element segment 320 and a hardened portion
340 located along the collapsible end portion. In further embodiments (not shown),
further hardened portions such as portion 340 may be located along a mesh flexible
tube, to provide means for further folding of the tube. Figs. 6B-6C show perspective
transparent views of vertical sections of collapsible end portion 310 of Fig. 6A in
different states while actuating element segment 320 is pulled. The hardened portion
may be formed, for example, by hardening a portion of the flexible tube that circumscribe
or partially circumscribe the flexible tube.
[0124] Collapsible end portion 310 may include hardened portion 340 located along collapsible
end portion 310 at a predefined distance from a tip of collapsible end portion 310.
Collapsible end portion 310 may further include hardened tip 330 located at the tip
of collapsible end portion 310. Hardened portion 340 may be tubular in order to allow
free passage of actuating element segment 320 through collapsible end portion 310.
[0125] When actuating element segment 320 is pulled proximally, collapsible end portion
310 may collapse into a section of an inner void of collapsible end portion 310 formed
between hardened tip 330 and hardened portion 340, as shown in Fig. 6B. As the pulling
of actuating element segment 320 continues, hardened portion 340 collapses into the
remainder of the inner void of collapsible end portion 310, as shown in Fig. 6C.
[0126] Reference is now made to Figs. 7A-7F. Fig 7A shows a perspective transparent view
of a collapsible end portion 355 of a mesh flexible tube 350 coupled with an actuating
element segment 360 and including a hardened tip with barbs located at two opposite
sides of the hardened tip. Figs. 7B-7C show perspective transparent views of vertical
sections of the collapsible end portion 355 of Fig. 7A in different states while actuating
element segment 360 is pulled. Fig 7D shows a perspective transparent view of a collapsible
end portion 380 of a mesh flexible tube 375 coupled with an actuating element 385
and including a hardened tip with barbs located at one side of the hardened tip. Figs.
7E-7F show perspective transparent views of vertical sections of collapsible end portion
380 of Fig. 7D in different states while actuating element segment 385 is pulled.
[0127] Collapsible end portion 355 may include a hardened tip 365. Hardened tip 365 may
include barbs 370 located at two opposite sides of hardened tip 365. When actuating
element segment 360 is pulled proximally and collapsible end portion 355 collapses,
barbs 370 may secure hardened tip 365 to collapsible end portion 355 by grasping collapsible
end portion 355 at two respective opposite locations. Collapsible end portion 380
may include a hardened tip 390. Hardened tip 390 may include barbs 395 located at
a side of hardened tip 390. When actuating element segment 385 is pulled proximally
and collapsible end portion 380 collapses, barbs 395 may secure hardened tip 390 to
collapsible end portion 380 by grasping collapsible end portion 380 at a respective
location. In some embodiments, hardened tips 365 and 390 may include barbs such as
barbs 370 and 395 in various numbers and located thereon according to various configurations.
[0128] In some embodiments, the disclosed devices may be used for repairing a tear in a
meniscus tissue. In some embodiments, such devices may include two collapsible end
portions and two actuating element segments, correspondingly. The two collapsible
end portions may be threaded through two apertures made in the meniscus tissue through
the tear in order to bring two edges of the tear closer together. When the two actuating
element segments are pulled proximally, the flexible tube may be anchored against
a peripheral distal wall of the meniscus tissue thereby maintaining the tear closed,
either fully (i.e. opposing surfaces of the tear are in contact) or almost fully (i.e.
opposing surfaces of the tear are at a very short distance from each other, such as
1-2 tenths of a millimeter apart; the surfaces may contact each other at some points).
[0129] A kit for repairing a tear in a meniscus tissue is herein disclosed. The kit may
include an implant and an applicator. The implant may be similar to the devices disclosed
herein. The applicator may be configured to deploy the implant in the meniscus tissue.
The applicator may be used to puncture the meniscus tissue in order to form at least
one aperture passing through the tear. At least one collapsible end portion of a flexible
tube of the implant may be then threaded through the aperture in order to bring the
edges of the tear closer together. Pulling the actuating element segment which is
secured to the collapsible end portion may anchor the implant to the meniscus tissue
thus maintaining the tear closed.
[0130] Reference is now made to Figs. 8A-10. Fig. 8A shows a perspective top view of an
exemplary applicator 400 of a kit which includes two tubular needles when one of the
tubular needles is in an operative mode. The term "tubular needle", along the specification,
may relate to a needle having a circular cross section or any other shape of cross
section. Fig. 8B shows a perspective top view of exemplary applicator 400 of Fig 8A
when the other tubular needle is in an operative mode. Fig. 8C shows a perspective
top view of exemplary applicator 400 of Fig 8A when in a non-operative mode. Fig.
9A shows an isometric top view of a tubular needle 450 of an exemplary applicator.
Fig. 9B shows a cross section along line A-A of tubular needle 450 of Fig. 9A. Fig.
9C shows a cross-section along line B-B of tubular needle 450 of Fig. 9A. Fig. 10
shows a side view of a vertical section of an exemplary kit 500 including an applicator
505 and an implant 525.
[0131] Applicator 400 may include two tubular needles 410A and 410B. Applicator 400 may
further include a housing 430 configured to hold needles 410A and 410B and cover them
when applicator 400 is in a non-operative mode as show in Fig. 8C. Each of tubular
needles 410A and 410B may include an opening 410A and 410B, respectively and a rod
(not shown).
[0132] With reference to Figs. 9A-9C, tubular needle 450, which is similar to tubular needles
410A and 410B, may include a rod 460 and an opening 470. Tubular needle 450 may further
include a front opening 480. Tubular needle 450 may be configured to puncture the
meniscus tissue in order to form an aperture through the meniscus tissue. Opening
470 may be configured to allow insertion of a tip of a collapsible end portion of
a flexible tube of the disclosed implant into tubular needle 450. Rod 460 may be positioned
within tubular needle 450, i.e., in an inner void of tubular needle 450. Rod 460 may
be configured to maintain the tip of the collapsible end portion in place within tubular
needle 450. Opening 470 may be sufficiently long for enabling the disclosed implant
to exit the void of tubular needle 450.
[0133] Referring now to Fig. 10, applicator 505 may include a tubular needle 510, a rod
515 and an opening 520. Implant 525 may include a flexible tube 530 and an actuating
element segment 540. Flexible tube 530 may include a collapsible end portion 535.
Collapsible end portion 535 may optionally include a hardened tip 545. Hardened tip
545 may be inserted into tubular needle 510 through opening 520. Rod 515 may be then
pushed distally in order to hold collapsible end portion 535 against a distal rim
of opening 520, thereby maintaining hardened tip 545 in place, i.e., within a distal
portion of tubular needle 450.
[0134] Referring back to Figs. 8A-8C, applicator 400 is shown in Figs. 8A and 8B in operative
modes. In Fig. 8A, tubular needle 410A is projected from housing 430 in order to puncture
the meniscus tissue and deploy a respective collapsible end portion of the disclosed
implant in the meniscus tissue. Tubular needle 410B is in a non-operative mode and
therefore retracted. In Fig. 8B, tubular needle 410B is projected from housing 430
in order to puncture the meniscus tissue and deploy a respective collapsible end portion
of the disclosed implant in the meniscus tissue. Tubular needle 410A is in a non-operative
mode and therefore retracted. In Fig. 8C, applicator 400 is in a non-operative mode,
i.e., both tubular needles 410A and 410B are retracted into housing 430.
[0135] In some embodiments, a collapsible end portion of the disclosed implant may be deployed
in the meniscus tissue through another opening, such as top opening 480 of tubular
needle 450 of Figs. 9A-9C. In such embodiments, rode 460, for example, may be used
to push the implant out of tubular needle 450 through top opening 480 in order to
deploy it in the meniscus tissue.
[0136] In some embodiments, an applicator which includes only one tubular needle may be
used to deploy the disclosed implant, while including a flexible tube with two collapsible
end portions. Reference is now made to Fig. 11, which shows a top view of an exemplary
kit 550 including an applicator 560 and an implant 575, where applicator 560 includes
a tubular needle, and when implant 575 is positioned in applicator 560. Flexible mesh
tube 595 may include two collapsible end portions 580A and 580B and a middle portion
580. Each of the two collapsible end portions 580A and 580B may include a hardened
tip 585A and 585B, respectively. Applicator 560 may include a tubular needle 565,
two openings 570A and 570B and two corresponding rods. The rods may be positioned
within openings 570A and 570B and beneath flexible mesh tube 595 and hence not shown.
Implant 575 may include a flexible mesh tube 595 and two actuating elements 590A and
590B. Tubular needle 565 may be configured to puncture the meniscus tissue to form
two apertures in the meniscus tissue and deploy implant 575 through the two apertures
in the meniscus tissue. Each of openings 570A and 570B may be configured to allow
insertion of hardened tips 585A and 585B into tubular needle 565, respectively. Optionally,
openings 570A and 570B may be partiotioned.
[0137] Implant 575 may be positioned in applicator 560, as shown in Fig.11 (i.e., in a U-shape)
in order to insert hardened tips 585A and 585B into openings 570A and 570B, respectively.
The two rods may be then pushed distally within openings 570A and 570B, respectively,
in order to maintain hardened tips 585A and 585B in place.
[0138] Reference is now made to Fig. 12 which shows a flowchart of a method for joining
at least two elements, constructed and operative in accordance with an embodiment
of the disclosed technique. In a step 600, a first aperture passing through the at
least two elements is formed. The first aperture may be formed in the two or more
elements by entering through the most proximal element of the two or more elements,
passing through all of the other elements to be joined and exiting through the most
distal element.
[0139] In a step 605, a first collapsible end portion of a flexible tube may be threaded
through the first aperture, entering through the most proximal element and exiting
through the most distal element. The flexible tube may be the flexible tube of the
disclosed devices.
[0140] In a step 610, a first actuating element segment secured to the first collapsible
end portion may be pulled proximally. The first actuating element segment may extend
along the first collapsible end portion. The first collapsible end portion may then
collapse proximally and form a bulge larger than the first aperture, thereby anchoring
the flexible tube against a rim of the first aperture.
[0141] Optionally, the first actuating element segment may extend along an inner void of
the first collapsible end portion and may exit the flexible tube through a middle
portion of the flexible tube, as shown in Figs. 3A-3D with respect to flexible mesh
tube 110. The pulling of the first actuating element segment proximally may then collapse
the collapsible end portion into its inner void.
[0142] Optionally, the first actuating element segment may be threaded laterally and repeatedly
through a the first collapsible end portion, as shown in Figs. 5A and 5C with respect
to flexible mesh tubes 200 and 250. The pulling of the first actuating element segment
proximally may then fold the first collapsible end portion laterally and repeatedly
on itself, as shown in figs. 5B and 5D.
[0143] Optionally, the first collapsible end portion may include a hardened portion located
along the first collapsible end portion at a predefined distance from a tip of the
first collapsible end portion, as shown in Fig. 6A with respect to flexible mesh tube
300. Pulling of the first actuating element segment proximally may then collapse the
first collapsible end portion into a section of an inner void of the first collapsible
end portion formed between its tip and its hardened portion, as shown in Fig. 6B.
Further pulling of the actuating element segment proximally may, in addition, collapse
the hardened portion of the first collapsible end portion into the remainder of its
inner void, as shown in Fig. 6C.
[0144] Optionally, the first collapsible end portion may include a hardened tip. The first
actuating element segment may be secured to the hardened tip, advantageously to a
center of a bottom surface of the hardened tip, as shown in Figs. 3A 3D.
[0145] In an optional step 615, a second aperture passing through the at least two elements
may be formed. This step may be similar to step 600.
[0146] In case the at least two elements are separable, they may be arranged to assure firm
and effective joining of the two or more elements. The location of the entrance of
the first and/or second aperture in the most proximal element and/or the path of the
first and/or second aperture through the two or more elements may be selected to assure
firm and effective joining of the two or more elements.
[0147] In an optional step 620, the second collapsible end portion of the flexible tube
may be threaded through the second aperture. This step may be similar to step 605.
[0148] In a further optional step, the second collapsible end portion may be stretched distally,
thereby bringing the bulge formed over the distal rim of the first aperture closer
to the distal rim and a middle portion of the flexible tube closer to the proximal
element (i.e., a proximal surface of the most proximal element).
[0149] In an optional step 625, a second actuating element segment secured to the second
collapsible end portion may be pulled proximally. This step may be similar to step
620. The first actuating element segment and the second actuating element segment
may be pulled in a separate manner.
[0150] In an optional step, when the device includes two flexible separate actuating elements,
such as threads, the two separate actuating elements may be tied. Reference is now
made to Figs. 13A and 13B. Fig. 13A shows a side view of a vertical section of a device
including two separate and flexible actuating elements, when deployed and after pulling
of the actuating elements. Fig. 13B shows a side view of a middle portion of the device
of Fig. 13A, where the remainder of the actuating elements is tied. Tying of the remainder
of the actuating elements may further anchor the flexible tube to the at least two
elements and thereby the joining of these elements and/or may shorten the remainder
of the actuating elements (i.e., so it may not be left hanging).
[0151] In some embodiments, the disclosed methods may be used for repairing a tear in a
meniscus tissue. The method may then use the disclosed devices and kits for repairing
a tear in a meniscus tissue. In such a case, the at least two element to be joined
are a peripheral distal wall of the meniscus tissue (also known as the peripheral
portion of the meniscus) and a proximal wall of the meniscus tissue (also known as
the free end portion of the meniscus). The two collapsible end portions may be threaded
through two apertures made in the meniscus tissue through the tear in order to bring
two edges of the tear closer together. When the two actuating element segments are
pulled proximally, the flexible tube may be anchored against the peripheral distal
wall of the meniscus tissue thereby maintaining the tear closed.
[0152] Optionally, the first and/or second apertures may be formed by two tubular needles
of an applicator. The applicator may be similar to an applicator of the disclosed
kits.
[0153] The method may then further include an optional step, according to which a tip of
the first and/or second collapsible end portions is placed in the respective tubular
needle of the applicator. In another optional step, the rod located within the respective
tubular needle may be pushed distally in order to hold the first and/or second collapsible
end portion against a distal rim of the opening of the respective tubular needle.
Thus, the tip of the first and/or second collapsible end portion may be maintained
in place while the first and/or second collapsible end portion is threaded through
the first and/or second aperture. In a further optional step, when the applicator
is in place (i.e., beyond the distal rim of the respective first or second aperture)
the rod may be retracted proximally, thus letting the tip of the respective collapsible
end portion out of the respective tubular needle through the opening of the respective
tubular needle to lie beyond the distal rim of the respective first or second aperture
(i.e., on a distal surface of the distal element).
[0154] The distal stretching of the second collapsible end portion may be performed by pushing
the second tubular needle, which holds the tip of the second collapsible end portion
(i.e., by its rod), distally until the bulge formed over the distal rim of the first
aperture and the middle portion are brought closer to the distal rim of the first
aperture and the proximal element, respectively.
[0155] Reference is now made to Figures 14A-14E which show top views of an applicator 670
deploying an implant 680 in a meniscus tissue 660 according to the method of Fig.
12 (or simply "the method"). Applicator 670 may be similar to applicator 400 of Figs.
8A-8C. Implant 680 may be similar to implant 100 of Fig. 2. According to Fig. 14A,
applicator 670 which includes a first tubular needle 675A and a second tubular needle
675B positioned in a housing 700 (i.e. retracted) may be positioned facing the concave
side of a meniscus tissue 660. Meniscus tissue 660 includes a peripheral distal wall
710 and a proximal wall 715 with respect to applicator 670. Meniscus tissue 660 further
includes a longitudinal tear 665.
[0156] According to Fig. 14B, tubular needle 675A may be projected from housing 700 (i.e.,
in an operative mode) and a first aperture may be formed in meniscus tissue 660 by
tubular needle 675A through tear 665 according to step 600 of the method. Implant
680 (indicated in Figs. 14C-14E) may be located in applicator 670. Collapsible end
portion 685A of a flexible mesh tube of implant 680 (not indicated) may be located
within tubular needle 675A. Thus, at the same time, collapsible end portion 685A may
be threaded through the first aperture according to step 605 of the method.
[0157] According to Fig. 14C, tubular needle 675A may be retracted and thus position within
housing 700. Collapsible end portion 685A may be collapsed therefore forming a bulge
above a distal rim of the first aperture (not indicated), i.e. on peripheral distal
wall 710. The bulge may be formed by pulling actuating element 705A of implant 680
according to step 610 of the method. Tubular needle 675B may be projected from housing
700 while a rod 690B maintains a collapsible end portion 685B of the flexible mesh
tube in place within tubular needle 675B.
[0158] According to Fig. 14D, a second aperture may be formed in meniscus tissue 660 through
tear 665 by tubular needle 675B according to step 615 of the method. At the same time,
collapsible end portion 685B which may be maintained in tubular needle 675B may be
threaded through the second aperture according to step 620 of the method. Tubular
needle 675B and collapsible end portion 685B are positioned beyond peripheral distal
wall 710. Pushing tubular needle 675B distally may stretch collapsible end portion
685B thus bringing the bulge above the distal rim of the first aperture closer to
the distal rim and a middle portion 695 of the flexible mesh tube closer to proximal
wall 715. The threading of collapsible end portion 685B (i.e., while collapsible end
portion 685A is threaded and anchored) and the stretching of collapsible end portion
685B, may close tear 665.
[0159] According to Fig. 14E, tubular needles 675A and 675B are retracted and therefore
positioned within housing 700. Collapsible end portion 685B may be collapsed therefore
forming a bulge above a distal rim of the second aperture (not indicated), i.e. on
peripheral distal wall 710. The bulge may be formed by pulling actuating element 705B
of implant 680 according to step 625 of the method. Implant 680 may be then anchored
in a fixed manner to meniscus tissue 660 and tear 665 may be maintained closed.
[0160] The disclosed devices and kits may be operated according to the above disclosed methods.
[0161] A further device is herein disclosed. The device may include a flexible tube and
an actuating element. The flexible tube and the actuating element may be in the form
and/or made similar to the flexible tube and the actuating element segments of the
device disclosed herein above and referred by Figs. 1-7F, respectively, with the modification
described herein below. The flexible tube may include an end portion and a collapsible
end portion. The end portion may include a first elongated hardened element located
at a tip of the end portion. The collapsible end portion may include a second elongated
hardened element threaded thereon. The actuating element may be secured to the collapsible
end portion.
[0162] When the end portion and the collapsible end portion are threaded through two apertures,
respectively, and the actuating element is pulled proximally, the collapsible end
portion may collapse proximally and form a bulge in vicinity to the second elongated
hardened element. A length dimension of the first elongated hardened element may be
larger than the respective aperture. The bulge and a length dimension of the second
elongated hardened element may be larger than the respective aperture. As a result
of the above, the flexible tube may be anchored against a rim of each of the two apertures.
[0163] In some embodiments, the collapsible end portion may include a hardened tip and the
actuating element may be secured to the hardened tip.
[0164] Reference is now made to Figs. 15A and 15B, which show side views of an exemplary
device 720 including a flexible mesh tube 722 arranged in a U-shape, where flexible
mesh tube 722 includes two elongated hardened elements, in a non-collapsed mode and
in a collapsed mode, respectively. Device 720 may include flexible mesh tube 722 and
an actuating element 732. Flexible mesh tube 722 may include an end portion 724A,
a collapsible end portion 724B and a middle portion 726 there between. End portion
724A may include an elongated hardened element 728A. Collapsible end portion 724B
may include an elongated hardened element 728A threaded thereon. Optionally, collapsible
end portion 724B may include a hardened tip 730 and an opening 736 through which actuating
element, which may extend along an inner void of collapsible end portion 724B, may
exit the flexible mesh tube.
[0165] Device 720 is arranged in the Figs. 15A and 15B in a U-shape, which may be the operative
arrangement of device 720, i.e., the arrangement of device 720 when it is deployed.
End portion 724A may be threaded through a first aperture and collapsible end portion
724B may be threaded through a second aperture, such that each elongated hardened
element 728A and 728B is located distally with respect to a distal rim of the respective
aperture. Actuating element 723 may be then pulled proximally thus collapsing collapsible
end portion 724B to form a bulge in vicinity to elongated hardened element 728B, for
example, on elongated hardened element 728B, as shown in Fig. 15B. Thereby device
720 may be anchored to a distal rim of each of the apertures.
[0166] In some embodiments, the first and second elongated hardened elements may have an
involute shape, such as elongated hardened elements 728A and 728B. Reference is now
made to Figs. 16A and 16B. Fig. 16A shows a perspective view of a thread 740 when
twisted around itself to form an involute elongated hardened element. Fig. 16B shows
a side view of thread 740 of Fig. 16A including an involute elongated hardened element
735. Involute elongated hardened element 735 may be formed by an elongated and flexible
element, such as a thread 740. An end portion 744B of thread 740 may be twisted around
an end portion 744A of thread 740, as shown in Fig. 16A, in order to form an elongated
hardened element which is involute. Fig. 16B shows thread 740 when arranged to include
involute hardened element 732 between a remainder of each of end portions 744A and
744B. The remainder may be then removed.
[0167] In some embodiments, the first and second elongated hardened elements may be made
of polymer. Reference is now made to Figs. 17A-17C. Fig. 17A shows a cross-section
of an elongated hardened element 758 including a bore and made of polymer. Fig. 17B
shows a cross-section of an exemplary device 750 including two elongated hardened
elements such as elongated hardened element 758 of Fig. 17A and arranged in a U-shape.
Fig 17C shows a collapsible end portion of a flexible mesh tube of device 750 of Fig.
17B, when collapsed. Elongated hardened element 758 may be made of polymer. Elongated
hardened element 758 may include a bore 760, through which a flexible tube of the
disclosed device may be threaded.
[0168] Exemplary device 750 may be similar to device 720 of Figs. 15A and 15B with the modification
described herein below. Device 750 may include a flexible mesh tube 752 and an actuating
element 762. Flexible mesh tube 752 may include an end portion 754A, a collapsible
end portion 754B and a middle portion 756 there between. An end portion 754A may include
a hardened elongated element 758A. Optionally, end portion 754A may include a thickened
end 762. Collapsible end portion 754B may include a hardened elongated element 758B.
Optionally, collapsible end portion 754B may include a hardened end 764. Hardened
elongated element 758A and hardened elongated element 758B may be similar to elongated
hardened element 758 of Fig. 17A. Thus, each of hardened elongated element 758A and
hardened elongated element 758B may include a bore 760A and 760B, respectively, through
which each of end portion 754A and collapsible end portion 754B are threaded, respectively.
Thickened end 762 may be used to anchor end portion against hardened elongated element
758A. Actuating element may be secured to hardened tip 764, extend within collapsible
end portion 754B and exit flexible mesh tube 752 through an opening 766. When actuating
element 762 is pulled proximally, Collapsible end portion may collapse proximally
therefore forming a bulge in vicinity to hardened elongated element 758B. Hardened
elongated element 758B may include a length dimension larger than a second aperture
through which collapsible end portion 754B may be threaded. In addition, the bulge
may be larger than bore 760B, as shown in Fig. 17C. Thus, flexible mesh tube 752 may
be anchored against a distal rim of the second aperture.
[0169] In some embodiments, the disclosed devices may be used for repairing a tear in a
meniscus tissue. The end portion and the collapsible end portion may be threaded through
two apertures, respectively, made in the meniscus tissue through the tear in order
to bring two edges of the tear closer together. When the actuating element segment
is pulled proximally, the flexible tube may be anchored against a peripheral distal
wall of the meniscus tissue thereby maintaining the tear closed.
[0170] Kits for repairing a tear in a meniscus tissue are disclosed herein. Reference is
now made to Fig.18A, which shows a top transparent view of an exemplary kit 770 including
an applicator 772 and an implant 774. Applicator 772 may be similar to applicator
400 of Figs. 8A-8C and/or applicator 500 of Fig. 10, with the modifications disclosed
herein below. Implant 774 may be similar to implant 860 of Figs. 14A-14E with the
modifications disclosed herein below. Implant 774 may include a flexible tube such
as a flexible mesh tube 775 and an actuating element 782. Flexible mesh tube 775 may
include an end portion 776A and a collapsible end portion 776B. End portion 776A may
include a first elongated hardened element 778A. Collapsible end portion 776B may
include a second elongated hardened element 778B. Optionally, collapsible end portion
776B may include a hardened tip 784
[0171] Actuating element 782 may be secured to collapsible end portion 778B, and optionally
to hardened tip 784. First elongated hardened element 778A may be located at a tip
of end portion 776A. Second elongated hardened element 778B may be threaded on collapsible
end portion 776B. Optionally, first and second elongated hardened elements 778A and
778B may be involute. Optionally, first and second elongated hardened elements 778A
and 778B may be made of polymer and/or may be similar to elongated hardened elements
758A and 758B of Figs. 17A-17C.
[0172] Applicator 772 may include a first tubular needle 782A and a second tubular needle
782B. First tubular needle 782A may include a first rod 783A and a first opening 781A.
Second tubular needle 782B may include a second rod 783B and a second opening 781B.
First rod 783A and second rod 783B may be positioned within first tubular needle 782A
and second tubular needle 782B, respectively. First rod 783A may include a graded
tip. Second rod 783B may include a recess at its tip. Alternatively or additionally,
applicator 772 may include an opening which may be located laterally with respect
and in each of tubular needles 782A and 782B (i.e., a first and a second lateral opening,
not shown in this view).
[0173] End portion 776A and collapsible end portion 776B may be threaded through two apertures
by applicator 772, respectively. First tubular needle 782A may be configured to puncture
the meniscus tissue to form a respective aperture. First opening 781A or the lateral
opening may be configured to allow insertion of first elongated hardened element 778A
into first tubular needle 782A. First rod 783A may be configured to maintain a first
elongated hardened element 778A in place within first tubular needle 782A. Second
tubular needle 782B may be configured to puncture the meniscus tissue to form a respective
aperture. Second opening 781B or the second lateral opening may be configured to allow
insertion of second elongated hardened element 778B and collapsible end portion 776B
into second tubular needle 782B. Second rod 783B may be configured to maintain second
elongated hardened element 778B and collapsible end portion 776B in place within second
tubular needle 782B. The recess of second rod 783B may be configured to accommodate
hardened tip 784.
[0174] Actuating element 782 may be then pulled proximally. As a result of that, collapsible
end portion 776B may collapse proximally and form a bulge in vicinity to second elongated
hardened element 778B. A length dimension of first elongated hardened element 778A
may be larger than the respective aperture. The bulge and a length dimension of second
elongated hardened element 778B may be larger than the respective aperture, thereby
anchoring flexible mesh tube 775 against a peripheral distal wall of the meniscus
tissue.
[0175] Alternatively, any applicator known in the art may be used in order to deploy implant
774 in the meniscus tissue by puncturing the meniscus tissue to form two apertures
passing through the tear and threading end portion 778A and collapsible end portion
778B through the two apertures, respectively.
[0176] In some embodiments, kit 770 may include an applicator which includes only one tubular
needle configured to deploy implant 772 in the meniscus tissue. The applicator may
be similar to applicator 560 of Fig. 11 and/or to applicator 772 of Fig. 18A, with
modification as disclosed below.
[0177] Reference is now made to Fig.18B, which shows a top transparent view of another exemplary
kit 790 including an applicator 794 and an implant 792. Applicator 784 may include
a tubular needle 802. Tubular needle 802 may include an opening, which may be front
opening 803 and/or a lateral opening (not shown) and a rod (both not shown in this
view). Implant 792 may be similar to implant 775 of Fig. 18A. Implant 792 may include
a flexible mesh tube 804 and an actuating element 800. Flexible mesh tube 804 may
include an end portion 796A and a collapsible end portion 796B. End portion 796A may
include a first elongated hardened element 798A located at a tip of end portion 796A.
Collapsible end portion 796B may include a second elongated hardened element 798B
threaded thereon.
[0178] Front opening 803 may be configured to allow insertion of flexible mesh tube 804
into tubular needle 802. The rod may be positioned within tubular needle 802 and may
be configured to maintain flexible mesh tube 804 in place within the tubular needle
Tubular needle 802 may be configured to puncture the meniscus tissue to form the two
apertures and deploy implant 792 in the meniscus tissue.
[0179] In an alternative applicator (not shown), two elongated hardened elements may be
positioned within a pair of suitable side grooves inside an elongated needle. These
grooves may be disposed sequentially along the length of the elongated needle.
[0180] Reference is now made to Fig. 19, which shows a flowchart of another method for joining
at least two elements, constructed and operative in accordance with an embodiment
of the disclosed technique. The method may be similar to the method of Fig. 12 with
modifications as described below. In a step 810, two apertures may be formed through
the at least two elements. The apertures may be formed in the two or more elements
by entering through the most proximal element, passing through all of the other elements
to be joined and exiting through the most distal element.
[0181] In a step 812, an end portion of a flexible tube and a first elongated hardened element
located at a tip of the end portion may be threaded through a respective aperture
of the apertures, entering through the most proximal element and exiting through the
most distal element. The first elongated hardened element may be then placed beyond
a distal rim of the respective aperture (i.e., on a distal surface of the most distal
element). The flexible tube may be similar to the flexible tube of the disclosed devices.
[0182] In a step 814, a collapsible end portion of the flexible tube and a second elongated
hardened element threaded thereon may be threaded through a respective aperture of
the apertures, entering through the most proximal element and exiting through the
most distal element. The second elongated hardened element and at least a section
of the collapsible end portion extending distally there from may be placed beyond
a distal rim of the respective aperture (i.e., on a distal surface of the most distal
element).
[0183] Optionally, each of the first and second elongated hardened elements may have an
involute shape. Optionally, each of the first and second elongated hardened elements
may be made of polymer. Optionally, the collapsible end portion may include a hardened
tip. The actuating element may be secured to the hardened tip, advantageously to a
center of a bottom surface of the hardened tip, as shown in Figs. 15A-15B.
[0184] In a step 816, an actuating element secured to the collapsible end portion and extending
along the collapsible end portion may be pulled proximally. The section of the collapsible
end portion may then collapse proximally and form a bulge in vicinity to the second
elongated hardened element. A length dimension of the first elongated hardened element
may be larger than the respective aperture. The bulge and a length dimension of the
second elongated hardened element may be larger than the respective aperture. Thus,
the flexible tube may be anchored against the distal rim of each one of the two apertures
(i.e., against the distal surface of the most distal element).
[0185] In case the at least two elements are separable, they may be arranged to assure firm
and effective joining of the two or more elements. The location of the entrance of
the first and/or second aperture in the most proximal element and/or the path of the
first and/or second apertures through the other elements may be selected to assure
firm and effective joining of the two or more elements.
[0186] In a further optional step, the collapsible end portion may be stretched distally,
thereby bringing the bulge formed over the distal rim of the respective aperture closer
to the distal rim and a middle portion of the flexible tube closer to the most proximal
element (i.e., a proximal surface of the most proximal element). Thus, tightening
the joining of the two or more elements.
[0187] In some embodiments, the disclosed methods may be used for repairing a tear in a
meniscus tissue. The method may then use the disclosed devices and kits for repairing
a tear in a meniscus tissue. In such a case, the two or more elements to be joined
may include a peripheral distal wall of the meniscus tissue and a proximal wall of
the meniscus tissue. The end portion and the first elongated hardened element may
be threaded through a first aperture made in the meniscus tissue through the tear.
The collapsible end portion and the second elongated hardened element may be threaded
through a second aperture made in the meniscus tissue through the tear. Thereby bringing
two edges of the tear closer together. When the actuating element is pulled proximally,
the flexible tube may be anchored against the peripheral distal wall of the meniscus
tissue thus maintaining the tear closed.
[0188] Optionally, the first and second apertures may be formed by a first and a second
tubular needle of an applicator. The applicator may be similar to an applicator of
the disclosed kits.
[0189] The method may then further include an optional step, according to which the first
elongated hardened element may be placed in the first tubular needle of the applicator
parallelly with respect to the first tubular needle.
[0190] In another optional step, the collapsible end portion and the second elongated hardened
element may be placed in the second tubular needle of the applicator. The second elongated
hardened element may be placed parallelly with respect to the second tubular needle.
[0191] In a further optional step, a first rod located within the first tubular needle may
be pushed distally in order to hold the end portion against a distal rim of a first
lateral opening of the first tubular needle.
[0192] In another optional step, a second rod located within the second tubular needle may
be pushed distally in order to hold the flexible tube against a distal rim of a second
lateral opening of the second tubular needle. Thus, the first elongated hardened element
and the collapsible end portion and the second elongated hardened element may be maintained
in place, respectively, while the end portion and the collapsible end portion are
threaded through the first and second apertures, respectively.
[0193] In a further optional step, when the first needle is in place (i.e., beyond the distal
rim of the first aperture), the first rod may be retracted proximally, thus letting
the first elongated hardened element out of the first tubular needle through the first
lateral opening to lie beyond the distal rim of the first aperture (i.e., on a distal
surface of the peripheral distal wall). Alternatively, the first rod may be pushed
distally, thus letting the first elongated hardened element out of the first tubular
needle through a first top opening to lie beyond the distal rim of the first aperture
(i.e., on a distal surface of the peripheral distal wall).
[0194] In another optional step when the second needle is in place (i.e., beyond the distal
rim of the second aperture) the second rod may be retracted proximally. Thus, letting
the second elongated hardened element and at least an end section of the collapsible
end portion extending from the second elongated hardened element out of the second
tubular needle through the second lateral opening. Alternatively, the second rod may
be pushed distally. Thus, letting the second elongated hardened element and at least
an end section of the collapsible end portion extending from the second elongated
hardened element out of the second tubular needle through the second top opening.
The second elongated hardened element and at least the end section may then lie beyond
the distal rim of the second aperture (i.e., on a distal surface of the peripheral
distal wall).
[0195] The distal stretching of the second collapsible end portion may be performed by pushing
the second tubular needle, which holds the second elongated hardened element and at
least an end section of the collapsible end portion (i.e., by the second rod), distally.
This may be performed in order to bring the first elongated hardened element located
over the distal rim of the first aperture closer to the distal rim of the first aperture
and to bring the middle portion of the flexible tube closer to the proximal wall,
respectively, thereby further closing the tear.
[0196] Optionally, each of the first and second elongated hardened elements may have an
involute shape. Optionally, each of the first and second elongated hardened elements
may be made of polymer. Optionally, the collapsible end portion may include a hardened
tip and the actuating element may be secured to the hardened tip.
[0197] Reference is now made to Figs. 20A-20G, which show top views, partially transparent,
of an applicator 820 deploying an implant 822 in a meniscus tissue 826 according to
the method of Fig. 19 (or simply "the method"). Applicator 820 may be similar to applicator
772 of Fig. 18A. Implant 822 may be similar to implant 774 of Fig. 18A. According
to Fig. 20A, Applicator 820 may be positioned facing the concave side of meniscus
tissue 826. Applicator 820 may include a first tubular needle 830A and a second tubular
needle 830B. First tubular needle 830A may be projected from a housing 832 (i.e.,
in an operative mode) and second tubular needle 830B may be located in housing 832
(i.e., in a non-operative mode). An elongated hardened element 838B and at least an
end section of a collapsible end portion 836B are maintained within tubular needle
830B by a rod 834B (show in Fig. 20D). A rod 834A positioned within tubular needle
830A may be pushed proximally in order to maintain an elongated hardened element 838A
within a tubular needle 830A. Rod 830A may include a graded tip 846. Meniscus tissue
826 may include a peripheral distal wall 848 and a proximal wall 850 with respect
to applicator 820. Meniscus tissue 826 may further include a longitudinal tear 828.
[0198] According to Fig. 20B, tubular needle 830A may puncture meniscus tissue 826 at proximal
wall 850 to form a first aperture through tear 828 according to step 810 of the method.
Therefore threading elongated hardened element 838A and following that, an end portion
836A of mesh flexible tube 824 of implant 822, through the first aperture, according
to step 812 of the method.
[0199] According to Fig. 20C, rod 834A may push elongated hardened element 838A through
a top aperture 854A of tubular needle 830A out of tubular needle 830A. Alternatively,
rod 834A may be retracted proximally, thus letting elongated hardened element 838A
out through a lateral aperture (not shown) of tubular needle 830A.
[0200] According to Fig. 20D, tubular needle 830A may be retracted and thus position within
housing 832. Elongated hardened element 838A may be placed above a distal rim of the
first aperture (not indicated), i.e. on peripheral distal wall 848.
[0201] According to Fig. 20E, a second aperture may be formed in meniscus tissue 826 through
tear 828 by tubular needle 830B according to step 810 of the method. At the same time,
elongated hardened element 838B and collapsible end portion 836B maintained in tubular
needle 830B may be threaded through the second aperture according to step 814 of the
method.
[0202] According to Fig. 20F, rod 834B may be pushed distally in order to push elongated
hardened element 838B out of tubular needle 830B. Alternatively, rod 834B may be retracted
proximally, thus letting elongated hardened element 838B and collapsible end portion
836B out through a lateral aperture (not shown) of tubular needle 830B. Pushing rod
834B distally may further stretch flexible mesh tube 822, thereby bringing the bulge
formed over the distal rim of the first aperture closer to the distal rim and middle
portion 840 closer to proximal wall 850 (i.e., a proximal surface of proximal wall
850). Thus, tightening the joining of the edges of tear 828 (i.e., closing tear 828).
[0203] According to Fig. 20G, tubular needle 830B may be retracted and therefore positioned
within housing 832, while leaving elongated hardened element 838B and collapsible
end portion 836B lying beyond the distal rim of the second aperture.
[0204] According to Fig. 20H, an actuating element 852 of implant 822 may be pulled proximally
according to step 816 of the method, (the direction of the pulling is indicated by
an arrow and the letter "F"). As a result of that, collapsible end portion 836B may
be collapsed therefore forming a bulge above a distal rim of the second aperture (not
indicated), i.e. on peripheral distal wall 848. Implant 822 may be then anchored in
a fixed manner to meniscus tissue 826 and tear 828 may be maintained closed.
[0205] A further device is herein disclosed. The device may include a flexible tube and
an actuating element. The flexible tube and the actuating element may be in the form
and/or made similar to the flexible tube and the actuating element segments of the
devices disclosed herein above, with the modification described herein below. The
flexible tube may include a first and a second end portion. The first end portion
may include a first elongated hardened element located at a tip of the end portion.
The second end portion may include a second elongated hardened element threaded thereon,
a pulling anchor located along the second end portion and a collapsible segment extending
from the pulling anchor towards a middle portion of the flexible tube. The actuating
element may be secured to the pulling anchor and extend therefrom along the second
end portion towards the middle portion of the flexible tube.
[0206] When the first end portion is threaded through a first aperture, and the second end
portion is threaded back and forth, at least once, through a second aperture, and
such that the second elongated hardened element and the pulling anchor are located
at different sides with respect to the second aperture, the actuating element may
be pulled proximally. As a result, the collapsible segment of the second end portion
may collapse towards the second elongated hardened element and form a bulge larger
than the second aperture. In addition, the first aperture may be smaller than a length
dimension of the first elongated hardened element and the second aperture smaller
than a length dimension of the second elongated hardened element. Thus, the flexible
tube may be anchored against a rim of the first aperture and two rims at two sides
of the second aperture.
[0207] The first and second elongated hardened elements may be similar to the elongated
hardened elements of the above disclosed devices, as described, for example, with
respect to Figs. 15A-17C. Optionally, each of the first and second elongated hardened
elements may have an involute shape. Optionally, each of the first and second elongated
hardened elements may be made of polymer.
[0208] Reference is now made to Figs. 21A and 21B. Fig. 21A shows a side view of a device
860 when it is arranged in a U-shape. Fig. 21A shows a side view of a portion of device
860 of Fig. 21A including a second end portion of a flexible mesh tube of device 860
and an actuating element of the device. Device 860 may include a flexible mesh tube
862 and an actuating element 874. Flexible mesh tube 862 may include a first end portion
864A, a second end portion 864B and a middle portion 866. First end portion 864A may
include a first elongated hardened element 868A. Second end portion 864B may include
a second elongated hardened element 868B, a pulling anchor 870 and a collapsible segment
876. Flexible mesh tube 862 may further include an aperture 872. First elongated hardened
element 868A may be located at a tip of first end portion 864A. Second elongated hardened
element 868B may be threaded on second end portion 864B, e.g., by a loop 878. Actuating
element 874 may be secured to pulling anchor 870 and may extend therefrom along second
end portion 864B towards middle portion 866. Actuating element 874 may exit flexible
mesh tube 862 through an aperture 872. Collapsible segment 876 may extend from pulling
anchor 870 towards middle portion 866.
[0209] Pulling anchor 870 may be formed by melting flexible mesh tube 862 and/or by over-molding,
as discussed above. Alternatively, pulling anchor 870 and any other pulling anchor
of the specification may be formed by any other technique for localized circumferential
narrowing of flexible mesh tube 862, such as by deploying a ring, a belt, a thread
and/or the like around the flexible mesh tube.
[0210] In some embodiments, the disclosed devices may be used for repairing a tear in a
meniscus tissue. The first and second end portions may be threaded through two apertures,
respectively, made in the meniscus tissue through the tear in order to bring two edges
of the tear closer together. When the actuating element segment is pulled proximally,
the flexible tube may be anchored against a peripheral distal wall and a proximal
wall of the meniscus tissue thereby maintaining the tear closed.
[0211] A kit for repairing a tear in a meniscus tissue is herein disclosed. The kit may
include and implant, similar to implant 860 of Figs. 21A and 21B, and an applicator.
The applicator may be configured to deploy the implant in the meniscus tissue by puncturing
the meniscus tissue to form two apertures passing through the tear and threading the
first end portion and the second end portion of the flexible mesh tube of the implant
through the two apertures, respectively. The applicator may be similar to applicator
770 of Fig. 18A or applicator 790 of Fig. 18B.
[0212] The first end portion may be threaded through a first aperture and the second end
portion may be threaded back and forth, at least once, through a second aperture,
by the applicator. The threading may be performed such that the second elongated hardened
element and the pulling anchor are located at different sides with respect to the
second aperture. The actuating element may be then pulled proximally. As a result,
the collapsible segment of the second end portion may collapse towards the second
elongated hardened element and form a bulge larger than the second aperture. In addition,
the first aperture may be smaller than a length dimension of the first elongated hardened
element and the second aperture smaller than a length dimension of the second elongated
hardened element. Thus, the flexible tube may be anchored against a rim of the first
aperture and two rims at two sides of the second aperture.
[0213] Reference is now made to Fig. 22, which shows a flowchart of a further method for
joining at least two elements, constructed and operative in accordance with an embodiment
of the disclosed technique. In a step 910, a first and a second aperture passing through
the at least two elements may be formed.
[0214] In a step 902, a first end portion of a flexible tube and a first elongated hardened
element located at a tip of the first end portion may be threaded through the first
aperture. The first elongated hardened element may be then placed beyond a distal
rim of the first aperture.
[0215] In a step 914, a second end portion of the flexible tube may be threaded back and
forth through the second aperture. A second elongated hardened element threaded on
the second end portion and a pulling anchor located along the second end portion may
be then placed at different sides with respect to the second aperture.
[0216] In a step 916, an actuating element secured to the pulling anchor and extending along
the second end portion may be pulled proximally. As a result of that, a collapsible
segment of the second end portion, extending from the pulling anchor towards a middle
portion of the flexible tube, may collapse towards the second elongated hardened element
and form a bulge larger than the second aperture. A length dimension of the first
elongated hardened element may be larger than the first aperture, and a length dimension
of the second elongated hardened element may be larger than the second aperture, thereby
anchoring the flexible tube to the two elements.
[0217] In some embodiments, the disclosed method may be used for repairing a tear in a meniscus
tissue. The method may then use the disclosed devices and kits for repairing a tear
in a meniscus tissue. In such a case, the two or more elements to be joined may include
a peripheral distal wall of the meniscus tissue and a proximal wall of the meniscus
tissue. The first end portion and the first elongated hardened element may be threaded
through a first aperture made in the meniscus tissue through the tear. The second
end portion and the second elongated hardened element may be threaded through a second
aperture made in the meniscus tissue through the tear. Thereby bringing two edges
of the tear closer together. When the actuating element is pulled proximally, the
flexible tube may be anchored against the peripheral distal wall and the proximal
wall of the meniscus tissue thus maintaining the tear closed.
[0218] Reference is now made to Figs. 23A-23E, which show side and perspective views of
an implant 880 deployed in a meniscus tissue 896 according to the method of Fig. 22.
[0219] According to Fig. 23A, a meniscus tissue 896 may be punctured in two locations in
a proximal wall 900 of meniscus tissue 896 to form a first and a second apertures
passing through a tear 902 in meniscus tissue 896 and exiting meniscus tissue 896
through a peripheral distal wall 898 of meniscus tissue 896, according to step 910
of the method. The puncturing may be performed by an applicator of the disclosed kits.
[0220] A first end portion 884A of a flexible tube 882 of implant 880 and a first elongated
hardened element 890A located at a tip of first end portion 884A may be threaded through
the first aperture by the applicator. Advantageously, while puncturing meniscus tissue
896. First elongated hardened element 890A may be placed beyond peripheral distal
wall 898. A second end portion 884B of flexible tube 882 of implant 880 may be threaded
back and forth through the second aperture by the applicator. A second elongated hardened
element 890B, threaded on second end portion 884B, and a pulling anchor 870 located
along second end portion 884B, may be placed at different sides with respect to the
second aperture (i.e., one beyond peripheral distal wall 898 and the other before
proximal wall 900).
[0221] According to Fig. 23B, end portion 884 may be stretched proximally (the direction
of pulling is indicated by an arrow and the letter "F") in order to close tear 902
by bringing elongated hardened element 890A closer to a distal rim of the first aperture,
middle portion 900 closer to proximal wall 900 and elongated hardened element 890B
closer to a distal rim of the second aperture.
[0222] According to Fig. 23C and 23D, an actuating element 894 of implant 860 may be pulled
proximally (the pulling direction is indicated by an arrow and the letter "F"). Actuating
element 894 may be secured to pulling anchor 892 and may extend along second end portion
884B. As a result of that, collapsible segment 892 of second end portion 884B, extending
from pulling anchor 892 towards middle portion 866 of flexible tube 862, may collapse
towards second elongated hardened element 890B and form a bulge. The bulge may be
larger than the second aperture. Optionally, the bulge may be of a size such that
to allow the bulge to enter the second aperture and stopped there within.
[0223] According to Fig. 23E, flexible tube 882 and therefore implant 880 may be firmly
anchored to meniscus tissue 896. This may be achieved since a length dimension of
first elongated hardened element 890A may be larger than the first aperture, and a
length dimension of second elongated hardened element 890B may be larger than the
second aperture.
[0224] A flexible tube according to the disclosed devices, kits and methods, which may be
used in medical procedures, may be made of materials such as polyester (for example,
DYNEEMA®, by Koninklijke DSM N.V. of TE Heerlen, Netherlands), nylon or a medical
suture. The flexible mesh tube may be formed by braiding, knitting or weaving. A length
of a flexible tube according to the disclosed devices, kits and methods for repairing
a meniscus tissue may range between 8 to 55 millimeters, 20 to 40 millimeters, 25
to 35 millimeters, 8 to 20 millimeters or 40 to 55 millimeters. A diameter of a bulge
formed by a portion of a flexible tube according to the disclosed devices, kits and
methods used in medical procedures may be between 1 to 8 millimeters, 3 to 7 millimeters,
5 to 6 millimeters, 1 to 3 millimeters or 6 to 8 millimeters.
[0225] An actuating element or an actuating element segment according to the disclosed devices,
kits and methods, which may be used in medical procedures, may be made of materials
such as polyester (for example, DYNEEMA®), nylon or a suture. A length of an actuating
element or an actuating element segment according to the disclosed devices, kits and
methods for repairing a meniscus tissue may range between 8 to 55 millimeters, 20
to 40 millimeters, 25 to 35 millimeters, 8 to 20 millimeters or 40 to 55 millimeters.
A thickness of an actuating element or an actuating element segment according to the
disclosed devices, kits and methods used in medical procedures for joining soft tissues
may range between 0.05 to 1.2 millimeter, 0.3 to 1.0 millimeters, 0.5 to 0.8 millimeters,
0.1 to 0.3 millimeters or 0.8 to 1.2 millimeters. A thickness of an actuating element
or an actuating element segment according to the disclosed devices, kits and methods
used in medical procedures for joining sclerous tissues may range between 1 to 17
millimeter, 5 to 14 millimeters, 8 to 11 millimeters, 1 to 4 millimeters or 13 to
17 millimeters.
[0226] A volute elongated hardened element according to the disclosed devices, kits and
methods, which may be used in medical procedures, may be made of materials such as
polyester (for example, DYNEEMA®), nylon or a suture. A thickness of a thread used
to form a volute elongated hardened element according to the disclosed devices, kits
and methods, which are used in medical procedures for joining soft tissues may range
between 0.05 to 1.2 millimeter, 0.3 to 1.0 millimeters, 0.5 to 0.8 millimeters, 0.1
to 0.3 millimeters or 0.8 to 1.2 millimeters. A thickness of a thread used to form
a volute elongated hardened element according to the disclosed devices, kits and methods
used in medical procedures for joining sclerous tissues may range between 0.5 to 5
millimeter, 1 to 4 millimeters, 2 to 3 millimeters, 0.5 to 2 millimeters or 3 to 5
millimeters. A length of an elongated hardened element according to the disclosed
devices, kits and methods, which are used for meniscus repair, may range between 2
to 11 millimeter, 4 to 9 millimeters, 6 to 7 millimeters, 2 to 5 millimeters or 9
to 11 millimeters. A width of an elongated hardened element according to the disclosed
devices, kits and methods, which are used for meniscus repair, may range between 0.5
to 3 millimeter, 1 to 2.5 millimeters, 1.5 to 2 millimeters, 0.5 to 1.5 millimeters
or 2 to 3 millimeters.
[0227] Reference or description of one end portion of a flexible tube of the disclosed devices
and kits, may also apply to the other end portion of the flexible tube.
[0228] The devices, kits and methods disclosed with respect to repairing of a meniscus tissue,
may also apply to the devices, kits and methods for joining two elements, with the
required modifications.
[0229] The disclosed devices and kits may be operated according to the disclosed methods.
[0230] The descriptions of the various embodiments of the present disclosure have been presented
for purposes of illustration, but are not intended to be exhaustive or limited to
the embodiments disclosed. Many modifications and variations will be apparent to those
of ordinary skill in the art without departing from the scope of the described embodiments.
The terminology used herein was chosen to best explain the principles of the embodiments,
the practical application or technical improvement over technologies found in the
marketplace, or to enable others of ordinary skill in the art to understand the embodiments
disclosed herein.